Category - Developments

Developments

FDA clears Boston Cell Standards’ IHControls panel in breast cancer

Closely-held Boston Cell Standards received 510(k) clearance from the FDA for its IHControls panel (HER2/ER/PR) for evaluating breast cancers, representing a first-in-category regulatory approval. IHControls are the...

October 6, 2022

Developments

FDA clears Annovis Bio for Phase 2/3 AD study

The FDA approved the development plan and study protocol for Annovis Bio (NYSE:ANVS) to proceed with a Phase 2/3 clinical study of buntanetap in moderate Alzheimer’s Disease (AD). In a statement, Maria...

October 6, 2022

Developments

Sigyn Therapeutics files U.S. patent entitled “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity”

Sigyn Therapeutics (OTCQB:SIGY) filed a provisional patent application entitled, “System and Methods to Enhance Chemotherapy Delivery and Reduce Toxicity,” with the United States Patent and Trademark Office. Cancer is...

October 6, 2022

Developments

FDA clears Tonix IND in major depressive disorder

The FDA approved Tonix Pharmaceuticals’ (NASDAQ:TNXP) IND application to support a Phase 2 clinical trial with TNX-601 ER, a once-daily formulation of tianeptine as a potential treatment for major depressive disorder...

October 3, 2022

Developments

VoxNeuro, CAF in study to measure training-related sub-concussive exposure

VoxNeuro, a closely-held software-as-a-medical-device (SaMD) brain health company, has partnered with the Canadian Armed Forces (CAF) to study the cognitive effects following intense military training regimens designed...

September 28, 2022

Developments

atai unit initiates Phase 1 trial for MDMA derivative EMP-01

EmpathBio, a unit of atai Life Sciences (NASDAQ:ATAI), received regulatory and ethics approval to begin enrollment of its Phase 1 study of EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment...

September 28, 2022

Developments

SAB Biotherapeutics presents new influenza and COVID-19 data

SAB Biotherapeutics (NASDAQ:SABS) presented new data at the Options for Control of Influenza conference in Belfast, showing its fully-human polyclonal antibody platform maintains its efficacy against multiple variants...

September 28, 2022

Developments

Maxim survey finds two-thirds of respondents planning to attend JMP

A survey of 150 people to a recent Maxim Group survey about the upcoming J.P. Morgan Healthcare Conference found that 69% of respondents are planning to attend the conference in person, while 52% would choose in person...

September 26, 2022

Developments

Profound Medical presents durable and stable positive 4-year trends from TACT pivotal trial

An investigator for Profound Medical (NASDAQ:PROF; TSX:PRN) presented four-year follow-up data from the TACT clinical study with Profound’s TULSA-PRO device that continue to demonstrate durable and stable safety and...

September 26, 2022

Developments

OpSens SavvyWire in first U.S. procedure

Dr. Philippe Genereux, director of the Structural Heart Program at Morristown Medical Center in New Jersey, and his team, performed the first use of OpSens’ (TSX:OPS; OTCQX:OPSSF) SavvyWire in a transcatheter aortic...

September 23, 2022

Category - Developments

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